Effectiveness of oral metronomic therapy vs supportive management in improving quality of life in metastatic and recurrent head and neck cancer: A randomized controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to evaluate the effectiveness of oral metronomic therapy (OMT) in improving the quality of life (QoL) using the EORTC QLQ-C30 and QLQ-HN35 questionnaire in patients with metastatic and recurrent head and neck cancer.
研究概览
简要总结
Head and neck cancer possess a very high symptom burden in patients especially in advanced stages. However, the treatment options in such patients ware very limited. Various studies have been conducted showing the uses of OMT in patients of palliative intent or in patient with resectable tumors. The outcomes have been measured in terms of disease progression, survival, and QoL. Not many studies have been conducted showing effectiveness of oral metronomic therapy especially in head and neck cancer patients with poor performance. This protocol aims to further evaluate the efficacy of OMT compared to supportive management in improving the QoL of patients with advanced stages of head and neck cancer.
This study plans to enrol a total of 200 patients with ECOGPS more than or equal to 2 with 100 patients in each study arm. Study conducted by Patil V (Patil et al 2020) reported a mean difference of -10 in the global health status (an effect size of 0.55) among those on OMCT at 6 months. However, the above study included only patients with ECOGPS less than or equal to 2. As the current study focusses on patients with ECOGPS more than or equal to 2, we assume a lower effect size of Global Health status at 6 months compared to that reported by Patil V. Assuming an effect size of 0.40 in this current study, a minimum of 78 patients are required in each arm at an alpha of 0.05 and 80% power. Given a dropout rate of approximately 20%, 94 patients in each arm will be required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients(more than or equal to eighteen years) diagnosed with metastatic or recurrent head and neck cancers.
- •Patients with Eastern Cooperative Oncology Group performance scale of more than or equal to two.
- •Patients who can understand either English or Hindi.
排除标准
- •Patients below eighteen years of age.
- •Patients with significant co-morbid conditions that preclude safe participation in the study.
- •Pregnant or breastfeeding women, due to potential drug teratogenicity.
- •Patients with a known contraindication to the drugs used in OMT(e.g., allergy to methotrexate or celecoxib).
- •Patients with ECOG PS more than or equal to two.
- •Patients who do not understand either Hindi or English.
结局指标
主要结局
The primary objective of this study is to evaluate the effectiveness of oral metronomic therapy (OMT) in improving the quality of life (QoL) using the EORTC QLQ-C30 and QLQ-HN35 questionnaire in patients with metastatic and recurrent head and neck cancer.
时间窗: At baseline, 2 months, 4 months and 6 months.
次要结局
- Overall Survival (OS): To evaluate overall survival as a secondary outcome,(determining if OMT extends survival times in comparison to supportive care.)
- Progression-Free Survival (PFS): To compare the progression-free survival rates between patients receiving OMT and those receiving supportive management.(This will be evaluated using radiological imaging and reporting at 3 months and 6 months.)
研究者
Dr Vishakha Pandey
All India Institute of Medical Sciences, New Delhi